3.1
NICE did a rapid review of the published literature on the efficacy and safety of this procedure. This comprised a comprehensive literature search and detailed review of the evidence from 9 sources, which was discussed by the committee. The evidence included 2 randomised controlled trials, 1 case control study, 5 case series and 1 review of US Food and Drug Administration MAUDE (Manufacturer and User Facility Device Experience) database. It is presented in the summary of key evidence section in the interventional procedures overview. Other relevant literature is in the appendix of the overview.